Enhanced Controlled Steering Functionality for Implant-Delivery Tools

Publication ID: 24-11857415_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Controlled Steering Functionality for Implant-Delivery Tools,” Published Technical Disclosure No. 24-11857415_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857415_0001_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,415.

Summary of the Inventive Concept

The inventive concept relates to a system and method for delivering an implant to a heart of a patient using a steerable delivery tool with improved controlled steering functionality, enabling more precise and efficient implant delivery.

Background and Problem Solved

The original patent disclosed a controlled steering functionality for an implant-delivery tool, which, although effective, had limitations in terms of precision and efficiency. The new inventive concept addresses these limitations by introducing a coupling mechanism, control unit, and sensor to enable axial advancement and rotational orientation of the second catheter relative to the first catheter, providing real-time feedback to the user.

Detailed Description of the Inventive Concept

The system comprises a first catheter with a steerable distal end portion and a second catheter with a steerable distal end portion, configured for advancement through a lumen of the first catheter. A coupling mechanism enables axial advancement and rotational orientation of the second catheter relative to the first catheter. A control unit, comprising a motor and gearbox, provides precise control over the axial advancement and rotational orientation of the second catheter. A sensor detects the position and orientation of the second catheter relative to the first catheter, providing real-time feedback to the user during the delivery of the implant. The method involves providing the first and second catheters, axially advancing and rotationally orienting the second catheter using the coupling mechanism and control unit, and delivering the implant to the heart of the patient.

Novelty and Inventive Step

The new inventive concept introduces a coupling mechanism, control unit, and sensor, which are not present in the original patent. These components enable precise control over the axial advancement and rotational orientation of the second catheter, providing real-time feedback to the user, which is not achievable with the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include different types of coupling mechanisms, control units, and sensors. For example, the coupling mechanism could be a magnetic or mechanical coupling, and the control unit could be a manual or automated system. The sensor could be an optical, electromagnetic, or ultrasonic sensor.

Potential Commercial Applications and Market

The inventive concept has potential commercial applications in the field of cardiac valve repair, enabling more precise and efficient implant delivery. The target market includes medical device companies, hospitals, and clinics specializing in cardiac surgery.

CPC Classifications

SectionClassGroup
A A61 A61F2/2427
A A61 A61B17/068
A A61 A61B17/105
A A61 A61F2/2445
A A61 A61F2/2466
A A61 A61M25/0054
A A61 A61M25/0068
A A61 A61M25/01
A A61 A61M25/0105
A A61 A61M25/0108
A A61 A61M25/0136
A A61 A61M25/0147
A A61 A61M25/0662
A A61 A61B2017/00305
A A61 A61B2017/00314
A A61 A61B2017/00323
A A61 A61B2017/00367
A A61 A61B2017/0649
A A61 A61B2017/293
A A61 A61B2090/0811
A A61 A61F2210/0014
A A61 A61F2250/001
A A61 A61F2250/0098
A A61 A61M25/005
A A61 A61M25/0133
A A61 A61M2025/0004
A A61 A61M2025/0006
A A61 A61M2025/015
A A61 A61M2025/0681

Field of Art

Medical device engineering, specifically interventional cardiology and catheter-based implant delivery systems, involving advanced medical device design, steerable catheter mechanisms, and minimally invasive surgical technologies

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with expertise in catheter design, mechanical engineering, and interventional cardiology techniques, possessing advanced degrees and 5-10 years of experience in developing steerable medical devices

Obviousness Rationale

A person having ordinary skill in the art would recognize that the published technical disclosure represents predictable variations and incremental improvements to the existing steerable catheter technology disclosed in the source patent. The additional components like the coupling mechanism, control unit, and sensor represent logical extensions of known medical device engineering principles applied to enhance precision and controllability of implant delivery systems. These modifications would be considered obvious combinations of known techniques to achieve improved functional outcomes in interventional medical procedures.

Obvious Combinations & Variations

Source Patent Element
Steerable catheter with pull wire mechanism for navigation through vasculature
PTD Variation
Adding a motor-driven control unit with gearbox for precise axial and rotational catheter positioning
Obviousness Reasoning
Motorization of medical device controls is a known technique for improving precision, and a PHOSITA would recognize the predictable benefit of automated positioning in complex medical interventions
Source Patent Element
First and second catheters configured for transluminal advancement
PTD Variation
Introducing a specific coupling mechanism allowing protruding connections between catheters for enhanced axial and rotational control
Obviousness Reasoning
Mechanical coupling designs are standard engineering solutions for improving device interoperability, representing a finite set of predictable design variations
Source Patent Element
Steerable catheter with distal portion capable of navigation
PTD Variation
Implementing a real-time sensor system to provide position and orientation feedback during implant delivery
Obviousness Reasoning
Integrating feedback sensors is a known method for improving medical device performance, representing an obvious enhancement to existing navigation technologies
Source Patent Element
Catheter with pull wire steering mechanism
PTD Variation
Replacing manual pull wire steering with a programmable motor-driven control system
Obviousness Reasoning
Replacing manual mechanical controls with automated systems is a predictable engineering evolution in medical device design
Source Patent Element
Basic catheter delivery system for cardiac interventions
PTD Variation
Adding a comprehensive control architecture with motor, gearbox, and feedback sensors
Obviousness Reasoning
Systematic enhancement of device control mechanisms represents an obvious optimization approach for medical device engineers seeking improved procedural precision
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857415 and the published technical disclosure, a person having ordinary skill in the art would find the claimed variations obvious and anticipated, as the disclosed improvements represent predictable combinations of known medical device engineering techniques applied to steerable catheter systems for cardiac interventions. The incremental modifications to catheter steering, positioning, and control mechanisms do not rise to the level of non-obvious innovation when viewed in light of the prior art.

Original Patent Information

Patent NumberUS 11,857,415
TitleControlled steering functionality for implant-delivery tool
Assignee(s)Edwards Lifesciences Innovation (Israel) Ltd.